Remote Monitoring in Cancer Care: A Platform Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-15

Study Completion Date

2025-04-17

Brief Summary

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This study investigates a device that closely monitors vital signs, as well as a smartphone application (app) that allows patients to respond to different questions and tests that will monitor for new symptoms. This study may help researchers understand if wearing the device is a better tool than standard vital sign assessment tools done only while at the doctor's office or hospital, and if using the smartphone app is a better tool than standard assessment tools used while in the doctor's office or hospital.

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Detailed Description

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PRIMARY OBJECTIVES:

I. Develop patient-specific algorithms to predict the trajectory of cytokine release syndrome (CRS) and or neurotoxicity and time to escalation of medical intervention is needed. (Arm 1) II. Establish the validity for the use of mobile technology to assess neurologic symptoms remotely. (Arm 1) III. Compare the time to escalation of potential medical intervention between remote monitoring (RM) and standard care (SC) based on retrospective analysis of clinical trial data. (Arm 1) IV. Establish the feasibility for the use of wearable device for continuous, remote monitoring of physiologic parameters by quantifying false alerts and downstream clinical actions. (Arm 1) V. Define the range of physiologic variables associated with receipt of radiation and chemotherapy. (Arm 2) VI. Correlate PROs and physician rated CTCAE to biologic parameters. (Arm 2) VII. Establish the feasibility for the use of wearable device for continuous, remote monitoring of physiologic parameters by quantifying false alerts and downstream clinical actions. (Arm 2)

OUTLINE:

ARM 1: Patients undergoing CAR-T therapy use the Biofourmis wearable device(s) and smartphone app to answer a series of questions about health and neurologic symptoms a few times a day for 5 weeks.

ARM 2: Patients undergoing radiation therapy (RT) for head and neck, lung, or gastrointestinal cancers use the Biofourmis wearable device(s) for 60 to 90 days after completion of RT. Patients also use the smartphone app to answer a series of questions about health and neurologic symptoms before start of RT, after completion of RT, 3 months after completion of RT, and 1 year after completion of RT. In addition, patients complete weekly questionnaires regarding side effects and tolerance of the device.

Conditions

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Head and Neck Carcinoma Hematopoietic and Lymphoid Cell Neoplasm Lung Carcinoma Malignant Digestive System Neoplasm Malignant Solid Neoplasm

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Arm 1 (wearable device[s], smartphone app)

Patients undergoing CAR-T therapy use the Biofourmis wearable device(s) and smartphone app to answer a series of questions about health and neurologic symptoms a few times a day for 5 weeks.

Computer-Assisted Intervention

Intervention Type OTHER

Use smartphone app

Patient Monitoring

Intervention Type PROCEDURE

Wear Biofourmis wearable device(s)

Arm 2 (wearable device[s], smartphone app, questionnaires)

Patients undergoing radiation therapy (RT) for head and neck, lung, or gastrointestinal cancers use the Biofourmis wearable device(s) for 90 days after completion of RT. Patients also use the smartphone app to answer a series of questions about health and neurologic symptoms before start of RT, after completion of RT, 3 months after completion of RT, and 1 year after completion of RT. In addition, patients complete weekly questionnaires regarding side effects and tolerance of the device.

Computer-Assisted Intervention

Intervention Type OTHER

Use smartphone app

Patient Monitoring

Intervention Type PROCEDURE

Wear Biofourmis wearable device(s)

Questionnaire Administration

Intervention Type OTHER

Complete questionnaires

Interventions

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Computer-Assisted Intervention

Use smartphone app

Intervention Type OTHER

Patient Monitoring

Wear Biofourmis wearable device(s)

Intervention Type PROCEDURE

Questionnaire Administration

Complete questionnaires

Intervention Type OTHER

Other Intervention Names

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medical monitoring monitor

Eligibility Criteria

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Inclusion Criteria

* ARM 1: Age \>= 18 years
* ARM 1: Provide written informed consent
* ARM 1: Patients undergoing commercial CAR-T cell therapy in an outpatient setting
* ARM 2: Age \>= 18 years
* ARM 2: Provide written informed consent
* ARM 2: Patients with a plan to undergo radiation therapy for lung, gastrointestinal, or head and neck cancer